Calyxo Receives FDA Approval for Redesigned CVAC System to Treat Kidney Stones

Calyxo has received FDA clearance for its new, redesigned CVAC System, which enables a minimally invasive approach to kidney stone treatment, with more than 50 procedures yielding strong patient outcomes and consistently positive physician feedback.

Steerable ureteroscopic renal evacuation (SURE) using the original CVAC Aspiration System has been used to successfully treat more than 1,500 patients in the U.S., demonstrating that vacuum aspiration of stone fragments improves clinical outcomes. Calyxo reimagined its CVAC System to further enhance the SURE procedure. It is the world’s only complete stone clearance solution that integrates ureteroscopy, laser lithotripsy, irrigation and aspiration in one device. By incorporating direct visualization with dedicated irrigation channels and a large aspiration lumen, the new CVAC System enables effective and efficient aspiration of kidney stones.

By enabling the physician to continuously clear stone dust through passive aspiration during laser lithotripsy and then remove residual fragments through active vacuum aspiration, the SURE procedure with our new CVAC System leads to highly effective stone clearance. We are gratified with the overwhelmingly positive feedback from urologists thus far and we are looking forward to making the technology more widely available in the coming months,” said Joe Catanese, Ph.D, President & CEO of Calyxo.

“The most commonly used kidney stone treatments today do not reliably remove all of the stone fragments and dust,” said endourologist Brian Eisner, MD, Director of Kidney Stone Program, Massachusetts General Hospital (MGH) and founding clinical advisor to Calyxo. “We know that vacuum aspiration of stone fragments during ureteroscopy with laser lithotripsy under direct visualization provides unique advantages to enable better stone clearance for our patients who, in some cases, will experience a less invasive procedure with a decreased need for additional treatments.” Dr. Eisner is a pioneer in the field of kidney stone care and Calyxo has licensed technology from MGH.

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